Abortion in First TrimesterNCT04056637
Choice of Modality of Follow up for Medication Abortion
A study testing Choice of follow-up option and Multi-level pregnancy test in people with Abortion in First Trimester, run by Stanford University at 1 site in United States.
Trial summary
This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Choice of follow-up option and Multi-level pregnancy test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for medication abortion <63 days gestational age
- In general good health
- English or Spanish speaking competency
- Willing and able to sign consent forms
Who cannot join
- Clients less than 18 years of age.
- Any client not meeting the inclusion criteria listed above will be excluded from participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.
This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.
- Conditions
- Abortion in First Trimester
- Being tested
- Choice of follow-up option, Multi-level pregnancy test
- Keywords
- MLPT, multi-level pregnancy test, medication abortion, first trimester abortion, abortion follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice of follow-up optionOther
Participant will be given the opportunity to choose from 3 follow-up options.
Multi-level pregnancy testDevice
Also called dBest
The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard of Care | No intervention | Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider. |
| Group 2: Flexible Follow-Up | Experimental | Participants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy Receives: Other: Choice of follow-up option; Device: Multi-level pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent follow-up after medication abortion by group
To compare rates of follow-up among clients who are instructed to come back to the clinic for in-person ultrasound medication abortion follow-up to clients who are given options for follow-up, including in-person ultrasound, repeat serum beta-hCG and MLPT
Measured: 5-14 days following mifepristone administration
Secondary outcomes (1)
Percent follow-up after medication abortion by follow-up type
To compare the overall proportion of follow-up completion among clients choosing their preferred method of follow-up (in-person ultrasound, repeat serum beta-hCG, MLPT strategy) (study period) to clients given only the option for in-person follow-up
Measured: 5-14 days following mifepristone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start9 Sep 2019
- Primary completion13 Mar 2020
- Study completion31 Mar 2020
Why it stopped: COVID-19 Impacted Service Delivery and Research Infrastructure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Gynuity Health Projects
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056637
- Sponsor's protocol ID
- 52312
- Status last verified
- May 2020
- First submitted
- 12 Aug 2019
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Modality of Follow up for Medication Abortion
- ClinicalTrials.gov ID
- NCT04056637
- Acronym / sponsor ID
- 52312
- Conditions
- Abortion in First Trimester
- Keywords
- MLPT, multi-level pregnancy test, medication abortion, first trimester abortion, abortion follow-up
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Impacted Service Delivery and Research Infrastructure
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Gynuity Health Projects
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the impact of providing medication abortion-seeking clients a choice for follow-up in practice. Clients presenting at or less than 63 days pregnant (based on last menstrual period) at the study site for first trimester medication abortion will be invited to participate. We hypothesize that providing clients with flexible follow-up options will improve follow-up rates.
This study is not to assess efficacy or safety of follow-up methods--that has been well established in practice and research. This is to assess choice of follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard of Care | No intervention | –Participants will be asked to complete follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider. |
| Group 2: Flexible Follow-Up | Experimental | Other: Choice of follow-up option, Device: Multi-level pregnancy testParticipants will be offered three follow-up options, including: 1) follow-up in clinic 1-2 weeks following mifepristone administration for an ultrasound and consultation with a provider; 2) repeat serum beta-hCG testing; 3) repeat multi-level pregnancy test strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible for medication abortion <63 days gestational age
- In general good health
- English or Spanish speaking competency
- Willing and able to sign consent forms
Key exclusion criteria (2 listed)
- Clients less than 18 years of age.
- Any client not meeting the inclusion criteria listed above will be excluded from participating in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choice of follow-up optionParticipant will be given the opportunity to choose from 3 follow-up options. | Other | Group 2: Flexible Follow-Up |
| Multi-level pregnancy testAlso: dBestThe Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT. | Device | Group 2: Flexible Follow-Up |
Primary outcome
Percent follow-up after medication abortion by group
Time frame: 5-14 days following mifepristone administration
To compare rates of follow-up among clients who are instructed to come back to the clinic for in-person ultrasound medication abortion follow-up to clients who are given options for follow-up, including in-person ultrasound, repeat serum beta-hCG and MLPT
1 secondary outcome
Percent follow-up after medication abortion by follow-up type
Time frame: 5-14 days following mifepristone administration
Results and safety
The study was stopped early (reason given: COVID-19 Impacted Service Delivery and Research Infrastructure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No. No data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choice of follow-up option and Multi-level pregnancy test in people with Abortion in First Trimester, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Impacted Service Delivery and Research Infrastructure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent follow-up after medication abortion by group (time frame: 5-14 days following mifepristone administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.